Composition, form of production and packaging
Drops of the eye and ear in the form of a clear solution from colorless to light yellow color.
1 ml
ciprofloxacin (in the form of hydrochloride) 3 mg
dexamethasone 1 mg
Excipients: benzalkonium chloride, disodium edetate, hydroxypropyl betacyclodextrin, hydrochloric acid, mannitol, water d / u.
5 ml - a vial of a dropper plastic (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
The drug with antibacterial and anti-inflammatory action for topical application in ophthalmology and ENT-practice. The therapeutic effect of the drug Combinil-Dou is due to the antibacterial action of ciprofloxacin and the anti-inflammatory effect of dexamethasone.
Ciprofloxacin is an antibacterial drug from the group of fluoroquinolones, it has a wide spectrum of action, has a bactericidal effect. The drug inhibits the DNA enzyme enzyme of bacteria, as a result of which DNA replication and the synthesis of bacterial cell proteins are disrupted. Ciprofloxacin acts both on multiplying microorganisms, and on those in rest. It is active against gram-negative microorganisms : Esherichia coli, Salmonella spp., Shigella spp., Proteus spp. (indole-positive and indole-negative), Morganella morganii, Citrobacter spp., Klebsiella spp., Enterobacter spp., Vibrio spp., Campylobacter spp., Hafnia spp., Providencia stuartii, Haemophilus influenzae, Pasteurella multocida, Pseudomonas spp., Gardnerella spp., Legionella pneumophila, Neisseria spp., Moraxella catarrhalis, Acinetobacter spp., Brucella spp., Chlamydia spp .; Gram-positive microorganisms: Staphylococcus spp., Streptococcus pyogenes, Streptococcus agalactiae, Sorennebacterium diphtheriae, Listeria monocytogenes.
Dexamethasone is a synthetic SCS. With topical application, the therapeutic activity of dexamethasone is due to anti-inflammatory, antiallergic and antiproliferative action. It reduces the permeability and proliferation of capillaries, local exudation, cellular infiltration, phagocytic activity, collagen deposition and fibroblast activity, inhibits the formation of scar tissue. Thus, dexamethasone reduces the main symptoms of inflammation.
PHARMACOKINETICS
When used in ophthalmology, ciprofloxacin penetrates well into various tissues of the eye, with the exception of the lens. C max occurs within 30 minutes, the highest concentration is observed in the moisture of the anterior chamber. Systemic reabsorption is observed. However, the drug concentration achieved in the blood is well below the detection limit and is not clinically relevant. Dexamethasone after digestion into the conjunctival sac penetrates well into the epithelium of the cornea and conjunctiva; while in the aqueous humor of the eye, therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the penetration rate increases.
When used in otorhinolaryngological practice with the introduction of a fixed combination of ciprofloxacin and dexamethasone in the auditory meatus, C max for ciprofloxacin is 1.55 ng / l, and for dexamethasone 0.86 ng / l. T 1/2 ciprofloxacin 2.9 hours, dexamethasone 2.8 hours.
The hydroxypropyl betacyclodextrin, which is part of the preparation as an auxiliary component, contributes to the long-term retention of the active substance on the front surface of the eye, thereby increasing the efficacy and duration of the drug.
INDICATIONS
Infectious and inflammatory diseases of the eye and its appendages:
- Acute and subacute conjunctivitis;
- keratitis;
- Anterior uveitis;
- blepharitis and other inflammatory diseases of the eyelids;
- prevention and treatment of infectious complications after wounds of the eye and its appendages and in operations on the eyeball.
Infectious-inflammatory diseases of the ear:
acute otitis externa;
- acute otitis media with a shunt of the tympanic membrane;
- Acute otitis media with granulations and otorei with a shunt of the tympanic membrane.
DOSING MODE
With infectious and inflammatory diseases, the eye and its appendages are instilled with 1-2 drops into the conjunctival sac every 4-6 hours. The first 24-48 hours of instillation can be performed every 2 hours.
The course of treatment for acute bacterial conjunctivitis, blepharitis - from 5 to 14 days, with keratitis - 2-4 weeks, for the prevention of inflammatory diseases after surgery with perforation of the eyeball - from 5 days to 1 month.
If the drug is used for more than 10 days, the patient's intraocular pressure should be monitored.
For infectious and inflammatory diseases of the ear , 4 drops are instilled into the external auditory canal of the affected ear 2 times / day for 7 days. Do not change the position of the head for 60 seconds to completely penetrate the medication into the auditory canal.
SIDE EFFECT
From the side of the organ of vision: horny infiltrates, burning, redness, itchy eyes, conjunctivitis, keratitis, periocular edema, foreign body sensation in the eye, photophobia, blurred vision, dry eyes, eyelid edema, conjunctival hyperemia, glaucoma and optic nerve damage, vision and narrowing of the fields of vision, cataract formation, secondary infection (fungal and bacterial), thinning of the cornea and / or perforation of the eyeball.
From the side of the organ of hearing: discomfort and pain in the ear, itching in the ear, stuffiness of the ear.
Other: edema of the face, delayed healing of wounds, taste perversions, skin rashes.
CONTRAINDICATIONS
- Herpetic keratitis and other viral lesions of the cornea and conjunctiva;
- tuberculosis of the eye;
- fungal lesions of the eyes;
- viral infections of the ear canal;
perforation of the tympanic membrane;
- children's age till 18 years;
- Pregnancy;
- the period of lactation (breastfeeding);
- Hypersensitivity to active substances or to any of the auxiliary ingredients of the drug.
PREGNANCY AND LACTATION
Contraindicated use of the drug during pregnancy and lactation.
SPECIAL INSTRUCTIONS
Prolonged use of eye drops can lead to an increase in intraocular pressure with subsequent damage to the optic nerve, a decrease in acuity and visual fields, as well as the formation of posterior subcapsular cataract. When using Cominil В® -Duo for more than 10 days, it is necessary to monitor the intraocular pressure.
In acute purulent infections of the eyes, corticosteroids may worsen or mask the symptoms of the disease.
Prolonged use of the drug may reduce the immune response and lead to the development of secondary infection of the eye.
Patients who use contact lenses should be removed before instilling the drug and re-dressing only after 20 minutes, since the preservative contained in the preparation may have an adverse effect on the eye tissue.
The bottle must be closed after each use. Do not touch the tip of the pipette to the eye.
Before applying ear drops, the external auditory canal should be sanitized (rinse and drain the external ear canal).
Before instillation of the drug into the external ear canal, it should be warmed to body temperature and held in hands for 1-2 minutes.
It is necessary to lie sideways or tilt your head to facilitate burial. To drip into the external ear canal specified number of drops. Allow the drops to drain into the external ear canal, pulling the earlobe down and back. Keep your head in the inverted position for about 2 minutes. You can put in the outer ear canal wool turunda.
Impact on the ability to drive vehicles and manage mechanisms
After the application of eye drops, it is possible to reduce the clarity of visual perception, so immediately after instillation it is not recommended to drive and engage in activities requiring increased attention and speed of psychomotor reactions.
OVERDOSE
Symptoms: local - the emergence of point keratitis, erythema, increased tear, edema and itching of the eyelids. There are no data on systemic manifestations of an overdose.
Treatment: there is no specific antidote. Rinse the eyes with water, cancel the drug and prescribe symptomatic therapy.
DRUG INTERACTION
Systemic absorption with local application is insignificant, therefore the probability of occurrence of medicinal interactions is extremely small.
Drugs that induce the activity of the isoenzyme CYP 3A4 (barbiturates, phenytoin, carbamazepine, rifampicin), can enhance the metabolism of GCS.
Drugs that inhibit the activity of CYP 3A4 (ketoconazole, macrolides), can potentially cause an increase in plasma corticosteroid levels.
Dexamethasone is a moderate inducer of CYP3A4. Joint reception with drugs metabolized with CYP3A4 (erythromycin) can increase their clearance, reducing their concentration in the plasma.
When ciprofloxacin is combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergy is usually observed;can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin and other beta-lactam antibiotics - with streptococcal infections; with isoxazolylpenicillins and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - with anaerobic infections.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.
After opening the bottle, the expiration date is 1 month.
